MAUDE Adverse Event Report: JIANGSU GUANGDA MEDICAL MATERIAL GROUP CO., LTD. LAP SPONGES; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Catalog Number 1-1818

Device Problems Nonstandard Device (1420); Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Root cause analysis: (b)(4) supplies part number 1-1818 to deroyal.In its supplier corrective action response (scar), (b)(4) concluded the root cause was a manufacturing error.All sponge packs are required to go through a weighing procedure to confirm correct piece count.One of the operators removed the sponge pack from the scale before the correct weight was read, which resulted in a miscount.Corrective action and/or systemic correction action taken: the supplier has indicated an automatic weight machine was installed in the beginning of 2015 for the counting procedure.If the weight of any pack of lap sponges deviates from the required parameter, the pack is automatically removed to the rejection bin.The defective lap sponge pack associated with this report was manufactured in march 2014 before the automatic weight machine was implemented.Refer to the attached photos of the automatic weight machine.Investigation summary: a complaint ((b)(4)) was received indicating that a pack of laparotomy sponges (part number 1-1818, lot number 1040303) contained four sponges instead of five.The raw material is supplied by (b)(4).The qc complaint specialist reviewed the 2013-2015 scar and supplier notification letter (snl) logs for similar complaints.No similar complaints were identified for part number 1-1818.However, similar complaints of miscounts were identified in association with the product line.Therefore, a scar was issued to (b)(4) and a response received on 10/15/2015.In its response, (b)(4) identified the raw material was produced prior to the implementation of an automatic weight counting machine.The qc complaint specialist reviewed the quality feedback investigation report for sales and similar complaint information.(b)(4).There have been no previous reports of miscounts reported for part number 1-1818.Preventive action: in its scar response, (b)(4) stated the automatic counting machine has been installed to prevent any miscount.This investigation is complete.If new and critical information is received, this report will be updated.(b)(4).

Event Description

The package of lap sponges only contained 4 sponges instead of 5.The sponges and package were saved and given to the clinical educator to forward to materials management.The original intended procedure was an exploration of l groin; repair of strangulated l femoral hernia; laparatomy; resection of small intestine.

• Brand Name: LAP SPONGES
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): JIANGSU GUANGDA MEDICAL MATERIAL GROUP CO., LTD.; 1286 humbracht cir; bartlett IL 60103
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 5188969
• MDR Text Key: 30327577
• Report Number: 2320762-2015-00020
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1-1818
• Device Lot Number: 1040303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1